A Phase 1a Study of PMN310 In Healthy Volunteers

Exclusion Criteria

• •1. Clinically significant 12-lead ECG abnormality at Screening.
• •2. Systolic blood pressure \> 150 bpm or diastolic blood pressure \> 90 bpm at Screening.
• •3. Experienced a significant systemic illness within 30 days of the first dose of study drug.
• •4. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
• •5. Currently using any medication except for acetaminophen as needed for miscellaneous aches and pains.
• •6. History of alcohol abuse and/or illicit drug use within 12 months prior dosing or a smoking history (use of tobacco products).
• •7. Unwilling to refrain from ingesting alcohol within the limits required by the Study.
• •8. Positive urine drug screen.
• •9. History of prior malignancy.
• •10. Documented history of human immunodeficiency virus (HIV) antibody or tested positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at Screening.
• •11. Donated blood or blood products (e.g., plasma, platelets) within 28 days prior to first dose.
• •12. Received an investigational agent within the last 30 days or 5 half-lives (if known) prior to Screening, whichever is longer.
• •13. Contraindication to brain venipuncture, MRI or LP.
• •14. Indication of potential suicidality risk as identified by the following Columbia-Suicide Severity Rating Scale (C SSRS).